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BZH — Meter, Peak Flow, Spirometry Class II

FDA Device Classification

FDA product code BZH covers "Meter, Peak Flow, Spirometry", a Class II medical device regulated under 21 CFR 868.1860. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
BZH
Device Class
Class II
Regulation Number
868.1860
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K253180microlife corporationMicrolife Digital Peak Flow Meter, Model PF200B (PF200B)June 23, 2026
K252802shenzhen bi-rich medical devices coPeak Flow Meter (PF-10(BR-PEF231))May 29, 2026
K241338chongqing moffy innovation technology coPeak Flow MeterDecember 31, 2024
K232588knox medical diagnosticsAluna 2November 25, 2024
K230423taian dalu medical instrument coElectronic Peak Flow MeterFebruary 23, 2024
K222810gostar coTD-7301 Peak Flow meterDecember 19, 2023
K203196shanghai sonmol medical equipment coPeak flow meterMay 26, 2021
K200832safey medical devices pvtSafey Peak Flow MeterJuly 30, 2020
K193311knox medical diagnosticsAlunaMarch 25, 2020
K191239guangzhou homesun medical technology coSmart Peak Flow MeterDecember 6, 2019
K180487breathe mePeak.meOctober 26, 2018
K181666mir medical international researchSmart OneAugust 1, 2018
K172804besmed health businessBesmed Peak Flow MeterJanuary 11, 2018
K170281beijing m and b electronic instruments coMSA100BT Peak Flow MeterOctober 6, 2017
K152276sparoWing Smart FEVI and Peak Flow MeterJune 3, 2016
K133975beijing m and b electronic instruments coMSA100 PEAK FLOW METEROctober 3, 2014
K123945monaghan medicalSTRIVE DUAL ZONE PEAK FLOW METERApril 17, 2013
K101380noble marketingRXPEAKFLOWSeptember 13, 2010
K092335k-jump health coPEAK EXPIRATORY FLOW METER, KN-9710April 9, 2010
K091412viasys healthcareCLEAN PEAK FLOW METERAugust 21, 2009

FDA data resources